There has been a demand for development of a pharmaceutical preparation capable of buccal disintegration or dissolution, which can be, if necessary, administered readily even without water, by aged people and children anywhere or anytime. Examples of prior art references disclosing such preparation are shown below.
JP-A H9(1997)-48726 discloses rapid buccal dissolution type preparations comprising a drug and a material wetting in a mouldable way on humidifying and retaining a shape after moulding and drying. Such material is exemplified by sugars, sugar alcohols, and water-soluble polymers.
JP-A H5(1993)-271054 (EP-A 553777) discloses a method of producing a rapid buccal dissolution type tablets comprising a pharmacologically active ingredient and sugars.
JP-A H9(1997)-71523 discloses tablets with rapid disintegration in the oral cavity which comprise a drug, crystalline cellulose, low-substituted hydroxypropylcellulose and a lubricant.
However, these prior art references nowhere disclose a solid preparation comprising (1) a pharmaceutically active ingredient, (2) one or more water-soluble sugar thereof selected from the group consisting of sorbitol, maltitol, reduced starch saccharide, xylitol, reduced paratinose and erythritol, and (3) low-substituted hydroxypropylcellulose having hydroxypropoxyl group contents of 7.0 to 9.9 percent by weight.
There has been a demand for development of a solid preparation which exhibits excellent buccal disintegration and dissolution and also an appropriate strength (hardness) such that the solid preparation never disintegrates or suffers damage in the course of the production steps or distribution stages.